- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01525173
A Safety and Efficacy Study of ALPHAGAN® P and LUMIGAN® in Subjects Previously Treated With Latanoprost for Glaucoma and Ocular Hypertension
October 7, 2013 updated by: Allergan
This study will evaluate the efficacy and safety of either bimatoprost 0.01% ophthalmic solution (Lumigan®) alone or bimatoprost 0.01% ophthalmic solution (Lumigan®) and brimonidine tartrate 0.1% ophthalmic solution (Alphagan® P) in combination in patients previously treated with latanoprost 0.005% ophthalmic solution monotherapy who require additional intraocular pressure (IOP) lowering medication.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
137
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Florida
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Deerfield Beach, Florida, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Ocular hypertension or glaucoma in at least 1 eye
- Visual acuity of 20/100 or better in both eyes
Exclusion Criteria:
- Corneal refractive laser surgery (LASIK, LASEK, PRK, RK) in the study eye(s)
- Intraocular or glaucoma surgery in the past 3 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: ALPHAGAN® P and LUMIGAN®
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.1% brimonidine tartrate ophthalmic solution (ALPHAGAN® P) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
|
1 drop of 0.1% brimonidine tartrate ophthalmic solution 3 times per day for 12 weeks.
Other Names:
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Names:
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
|
Active Comparator: LUMIGAN® Alone
1 drop of latanoprost 0.005% ophthalmic solution once daily in each eye as run-in therapy for 30 days followed by 1 drop of 0.2% hypromellose lubricant eye drops (used for masking purposes) 3 times per day and 1 drop of 0.01% bimatoprost ophthalmic solution (LUMIGAN®) once per day for 12 weeks.
|
1 drop of 0.01% bimatoprost ophthalmic solution once per day for 12 weeks.
Other Names:
1 drop of latanoprost 0.005% ophthalmic solution once daily as run-in therapy for 30 days only.
1 drop of 0.2% hypromellose lubricant eye drops 3 times per day for 12 weeks.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change From Baseline in Mean Diurnal Intraocular Pressure (IOP)
Time Frame: Baseline, Week 12
|
IOP is a measurement of the fluid pressure inside the eye.
IOP was measured in the study eye, defined as the worse eye at Baseline.
The mean diurnal IOP is the average of all the IOP measurements in the study eye taken at 8 AM, 10 AM and 4 PM at Baseline and at Week 12.
A negative change from Baseline indicated improvement.
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Baseline, Week 12
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2012
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
October 1, 2012
Study Registration Dates
First Submitted
January 31, 2012
First Submitted That Met QC Criteria
January 31, 2012
First Posted (Estimate)
February 2, 2012
Study Record Updates
Last Update Posted (Estimate)
December 4, 2013
Last Update Submitted That Met QC Criteria
October 7, 2013
Last Verified
October 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Eye Diseases
- Glaucoma
- Ocular Hypertension
- Hypertension
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Adrenergic alpha-2 Receptor Agonists
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Brimonidine Tartrate
- Ophthalmic Solutions
- Pharmaceutical Solutions
- Lubricant Eye Drops
- Bimatoprost
- Latanoprost
Other Study ID Numbers
- GMA-LUM-11-019
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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